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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019968
Company: SUN PHARM INDS INC

Products on NDA 019968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULTRAVATE	HALOBETASOL PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/1990	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/02/2012	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011ltr.pdf
09/17/2004	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19968s007ltr.pdf
07/12/1995	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/27/1993	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/04/1993	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/10/1993	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/31/1991	SUPPL-1	Efficacy-New Dosing Regimen		Label is not available on this site.

Labels for NDA 019968

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf
09/17/2004	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf

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